FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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India Ink: Image of the Day: Feb. 22

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Renée Zellweger Puckers Up with Doyle Bramhall II in Hawaii: Photo

By Andrea Billups

02/22/2013 at 11:30 AM EST

Doyle Bramhall II and Renée Zellweger

AKM-GSI

Renée Zellweger was feeling the love – and the surf – during her recent Hawaiian vacation.

Zellweger, 43, joined her boyfriend, musician Doyle Bramhall II, 44, for some kayaking, paddle-boarding and romantic kissing on the beach. Wearing matching black beachwear, the Texas natives were not shy about their happiness, holding hands and smiling broadly as they vacationed together.

But soon it's back to work for Zellweger, who's set to appear on the Oscar telecast Sunday in Los Angeles. The Academy Award winner will reportedly join her Chicago cast as presenters, marking the 10th anniversary of their musical film earning Best Picture honors.

Bramhall, a guitarist and songwriter who toured with Roger Waters and Eric Clapton, was last linked to Sheryl Crow in 2011.

The 85th annual Academy Awards will air live on ABC starting at 7 p.m. ET/4 p.m. PT on Sunday, Feb. 24, from the Dolby Theatre in Hollywood.

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FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla (kad-SY'-luh) from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a double-shot of anti-tumor poison.

Cancer researchers say the drug may offer a clear advantage over older drugs because it delivers more medication with fewer side effects.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was co-developed by South San Francisco-based Genentech and ImmunoGen Inc., of Waltham, Mass. ImmunoGen developed the technology that binds the drug ingredients together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 33 cents, or 2.27 percent, to $14.63 in midday trading.

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Wall Street rises on HP but S&P on track to end week lower

NEW YORK (Reuters) - Stocks rebounded on Friday as Hewlett-Packard, the largest personal computer maker, surged on strong results, but the S&P 500 index was on the way to end a streak of gains that has lasted seven straight weeks.

The S&P shed 1.9 percent over the previous two sessions, its worst two-day drop since early November, putting the index on pace for its first weekly decline of the year. The retreat was triggered when the Federal Reserve's meeting minutes for January suggested stimulus measures may be halted sooner than thought.

Still, the index is up nearly 6 percent for the year and held the 1,500 support level despite the recent declines, a sign of a positive bias in the market.

"The market is addicted to Fed stimulus and gets withdrawal shakes every time that's threatened, but now we're resuming our course and remain much more attractively valued than other asset classes," said Rex Macey, chief investment officer at Wilmington Trust in Atlanta, Georgia.

Hewlett-Packard Co jumped 9.6 percent to $18.74 as the top boost on both the Dow and S&P 500 after the PC maker's quarterly revenue and forecasts beat expectations. The company cut costs under Chief Executive Meg Whitman's turnaround plan. The S&P technology sector <.splrct> was up 0.6 percent.

The Dow Jones industrial average <.dji> was up 52.22 points, or 0.38 percent, at 13,932.84. The Standard & Poor's 500 Index <.spx> was up 5.25 points, or 0.35 percent, at 1,507.67. The Nasdaq Composite Index <.ixic> was up 13.45 points, or 0.43 percent, at 3,144.94.

For the week, the Dow is off 0.3 percent in its third straight week of slight losses, the S&P is off 0.7 percent and the Nasdaq is off 1.4 percent.

Also buoying tech stocks were gains in semiconductor companies after Marvell Technology Group Ltd forecast results this quarter that were largely above analysts' expectations as it gained market share in the hard-disk drive and flash-storage businesses.

In addition, Texas Instruments Inc raised its dividend by a third and boosted its stock buyback program. Texas Instruments rose 4.3 percent at $33.88 while Marvell added 2.2 percent at $9.67. The PHLX semiconductor index <.sox> gained 1.3 percent.

"Dividends growing are another way the market's level is justified, if not especially attractive at these levels," said Macey, who manages about $20 billion in assets.

On the downside, Abercrombie & Fitch dropped 7.3 percent to $45.49 after the clothing retailer reported a drop in fourth-quarter comparable sales, even as its latest quarterly earnings topped estimates.

Insurer American International Group Inc posted fourth-quarter results that beat analysts' expectations. Shares advanced 2.6 percent to $38.26.

According to Thomson Reuters data through Friday morning, of 439 companies in the S&P 500 that have reported results, 70 percent have exceeded analysts' expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters.

Fourth-quarter earnings for S&P 500 companies are estimated to have risen 6 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

(Editing by Kenneth Barry)

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India Ink: Image of the Day: Feb. 21

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Taylor Swift Channels Beyoncé at Brit Awards

By Aaron Parsley

02/21/2013 at 11:40 AM EST

Does Sasha Fierce have a pop-country cousin?

During a sassy performance of "I Knew You Were Trouble" at Wednesday's Brit Awards, Taylor Swift shed a white wedding dress to reveal a black embellished jumpsuit, sexy boots – and some familiar moves.

Striking a pose, tossing her hair and even falling to her knees to belt out the hit song, Swift, 23, resembled Beyoncé in her highly buzzed-about Super Bowl halftime performance on Feb. 3. Flip through a carousel of photos from the performance above.

At the awards ceremony at London's O2 arena, Swift handed out the best British female prize to soulful Scottish singer and songwriter Emeli Sandé, who also took home the best album prize for her debut, Our Version of Events.

A nominee for international female solo artist, Swift lost in that category to another American, Lana Del Rey.

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Adults get 11 percent of calories from fast food

ATLANTA (AP) — On an average day, U.S. adults get roughly 11 percent of their calories from fast food, a government study shows.

That's down slightly from the 13 percent reported the last time the government tried to pin down how much of the American diet is coming from fast food. Eating fast food too frequently has been seen as a driver of America's obesity problem.

For the research, about 11,000 adults were asked extensive questions about what they ate and drank over the previous 24 hours to come up with the results.

Among the findings:

— Young adults eat more fast food than their elders; 15 percent of calories for ages 20 to 39 and dropping to 6 percent for those 60 and older.

— Blacks get more of their calories from fast-food, 15 percent compared to 11 percent for whites and Hispanics.

— Young black adults got a whopping 21 percent from the likes of Wendy's, Taco Bell and KFC.

The figures are averages. Included in the calculations are some people who almost never eat fast food, as well as others who eat a lot of it.

The survey covers the years 2007 through 2010 and was released Thursday by the Centers for Disease Control and Prevention. The authors couldn't explain why the proportion of calories from fast food dropped from the 13 percent found in a survey for 2003 through 2006.

One nutrition professor cast doubts on the latest results, saying 11 percent seemed implausibly low. New York University's Marion Nestle said it wouldn't be surprising if some people under-reported their hamburgers, fries and milkshakes since eating too much fast food is increasingly seen as something of a no-no.

"If I were a fast-food company, I'd say 'See, we have nothing to do with obesity! Americans are getting 90 percent of their calories somewhere else!'" she said.

The study didn't include the total number of fast-food calories, just the percentage. Previous government research suggests that the average U.S. adult each day consumes about 270 calories of fast food — the equivalent of a small McDonald's hamburger and a few fries.

The new CDC study found that obese people get about 13 percent of daily calories from fast food, compared with less than 10 percent for skinny and normal-weight people.

There was no difference seen by household income, except for young adults. The poorest — those with an annual household income of less than $30,000 — got 17 percent of their calories from fast food, while the figure was under 14 percent for the most affluent 20- and 30-somethings with a household income of more than $50,000.

That's not surprising since there are disproportionately higher numbers of fast-food restaurants in low-income neighborhoods, Nestle said.

Fast food is accessible and "it's cheap," she said.

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Wall Street falls after raft of weak data

NEW YORK (Reuters) - U.S. stocks declined on Thursday as a ream of weak economic data did little to assuage some investors' concerns that the Federal Reserve may rein in its economic stimulus measures and amid uncertainty over ongoing budget talks in Washington.

The number of Americans filing new claims for unemployment benefits rose last week and consumer prices were flat in January, buttressing the argument for the Fed to continue its accommodative monetary policy.

On Wednesday, minutes from the U.S. Federal Reserve's most recent meeting suggested the central bank may slow or stop buying bonds sooner than expected. The news sent shares lower and the benchmark S&P 500 index dropped 1.2 percent, its biggest decline since November 14.

The Fed has used quantitative easing, or QE, since 2008 in a bid to stimulate the economy. The policy, which involves expanding the Fed's balance sheet to buy bonds, has been credited with pushing money into the stock market, and its withdrawal would remove a ballast for the markets.

The benchmark S&P index has dropped 1.9 percent over the past two sessions but is still up more than 5 percent for the year. That's led many analysts to believe that the Fed minutes, the upcoming sequestration in Washington and sluggish consumer spending may be triggers for an overdue pullback in equities.

The sequestration - automatic across-the-board spending cuts put in place as part of a larger congressional budget fight - are due to kick in March 1 unless lawmakers agree on an alternative.

"It's the sequester, it's the knee-jerk reaction to yesterday's Fed minutes and it's the realization the consumer is slowing," said Phil Orlando, chief equity market strategist, at Federated Investors, in New York.

"I'd love to see a healthy 5 percent correction; let's wash out some of the weak hands and set up for a better move during the year."

Financial data firm Markit said its "flash," or preliminary U.S. Manufacturing Purchasing Managers Index slowed to 55.2 this month from 55.8, which had been the best showing since April, 2012.

Wal-Mart Stores Inc , seen as a gauge of consumer spending, said U.S. sales weakness persisted into early February, as Americans absorbed the impact of higher payroll taxes and gasoline prices, along with slow tax refunds that put some spending on hold. But shares rose 2.2 percent to $70.73 to help curb declines on the Dow as earnings topped expectations.

The Dow Jones industrial average <.dji> dropped 64.01 points, or 0.46 percent, to 13,863.53. The Standard & Poor's 500 Index <.spx> lost 10.33 points, or 0.68 percent, to 1,501.62. The Nasdaq Composite Index <.ixic> fell 25.93 points, or 0.82 percent, to 3,138.48.

In a positive sign, data showed home resales edged higher in January and left inventory of homes at its lowest level in 13 years as the housing market continues to steadily improve.

But the Federal Reserve Bank of Philadelphia said its index of business conditions in the U.S. Mid-Atlantic region fell in February to minus 12.5, the lowest level in eight months, from minus 5.8 in January.

VeriFone Systems Inc tumbled 37.7 percent to $19.86 after the credit card swipe-machine maker forecast first and second-quarter profit that were well below analysts' expectations.

According to Thomson Reuters data through Thursday morning, of the 427 companies in the S&P 500 that have reported results, 69.3 percent have exceeded analysts' expectations, compared with a 62 percent average since 1994 and 65 percent over the past four quarters.

Fourth-quarter earnings for S&P 500 companies are estimated to have risen 5.9 percent, according to the data, above a 1.9 percent forecast at the start of the earnings season.

Berry Petroleum Co jumped 16.5 percent to $44.95 after oil and gas producer Linn Energy LLC said it would buy the company in an all-stock deal valued at $4.3 billion including debt. Linn Energy shares advanced 3 percent to $37.76.

(This story corrects share price on Berry Petroleum in last paragraph to $44.95, from $444.95)

(Editing by Bernadette Baum)

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IHT Rendezvous: True or False? The Tussle Over Ping Fu's Memoir

Did Ping Fu, a prominent Chinese-American businesswoman and author of a recent memoir, “Bend, not Break,” make up her horrible experiences during the 1966-76 Cultural Revolution in order to gain United States citizenship? Did they help her become an American by claiming political asylum?

That’s what her critics, many of them fellow Chinese-Americans, say. It’s an accusation that can stick. As a recent New York Times investigation showed, claiming persecution has spawned an immigration industry involving lawyers prepping clients to make false asylum claims.

As I write in my Letter from China this week, Ms. Fu is being accused of making up a lot of things in her memoir. She’s also a successful entrepreneur: the U.S. government honored Ms. Fu, the founder of the software company Geomagic (in the process of being sold to 3D Systems), with a “2012 Outstanding American by Choice” award.

Ms. Fu is on the board of the White House’s National Advisory Council on Innovation and Entrepreneurship, and is a member of the National Council on Women in Technology, according to the Web site of the U.S. Citizenship and Immigration Services.

Ms. Fu, who says in her memoir she was “quietly deported” to the U.S. in 1984 for writing about female infanticide while still a college student, denies the accusations. But until now she hadn’t explained in public how she became an American.

In an interview with the International Herald Tribune, she said, apparently for the first time, the reason she kept quiet was she was trying to protect her first husband, an American, whom she does not mention in her memoir. The marriage took place while she was living in California, she said.

“I had a first marriage and that’s how I got my green card,” she said by telephone. She married on Sept. 1, 1986 and divorced three years later. Until now she had kept silent because of a “smear” campaign against her online, mostly by fellow Chinese who accuse her of lying, which extended to real-life harassment, she said: “They smear my name, they try to get my daughter’s name on the Internet, they sent people to Shanghai to surround my family and to Nanjing to harass my neighbors.” She said the accusers, who are “angry” for reasons she doesn’t really understand, contacted U.S. immigration authorities to challenge her award and her citizenship, as well as shareholders of 3D Systems to warn them she was a “liar,” and not to buy Geomagic. Her second husband, Herbert Edelsbrunner, whom she has since divorced, received many “hate e-mails,” she said. “I just don’t want to hurt innocent people.”

If a first, unpublicized marriage might lay to rest one contentious issue, there are others. Some were the result of exaggeration or unclear communication with her ghostwriter, MeiMei Fox of Los Angeles, she said.

In the interview, she volunteered an example of an error: a widely criticized account of the ‘‘period police,’’ the authorities who checked a woman’s menstrual cycle to ensure she wasn’t pregnant in the early days of the one-child policy. To stop women substituting others’ sanitary pads for inspection, they were sometimes required to use their own finger to show blood. Through a misunderstanding with Ms. Fox, Ms. Fu said this was portrayed as the use of other people’s fingers — an invasion of the woman’s body.

Ms. Fox “wrote it wrong,’’ she said. ‘‘I corrected it three times but it didn’t get corrected.’’ Women used their own finger to show blood, she said, but the mistake went into print anyway.

In general, Ms. Fox may have ‘‘just made some searches on the Internet that maybe weren’t correct,’’ Ms. Fu said.

Chiefly the errors involved use of the words ‘‘all, never, any,’’ that generalized unacceptably, Ms. Fu said. And, ‘‘She doesn’t know China’s geography,’’ she said.

At the beginning of her memoir, Ms. Fu writes of being kidnapped by a Vietnamese-American on arrival in the U.S. state of New Mexico and locked in his apartment to care for his very young children, whose mother had left, in a bizarre incident. A spokeswoman at the Albuquerque Police Department’s Records Office, where the alleged kidnapping took place, said she could not locate such an incident in their records. Asked about it, Ms. Fu repeated that she did not press charges as, fresh from China, she was terrified of all police, “So I don’t know how they keep records, if there is no criminal charges or record.”

And in an e-mail to me, she admitted she made mistakes about a magazine she said she helped edit, called Wugou, or “No Hook,” produced in 1979 by students at her college, then called the Jiangsu Teacher’s College (later it changed its name to Suzhou University, she said.) It was not that magazine but another one, This Generation, that was taken to a meeting in Beijing of student magazine writers from around the country, she wrote in the e-mail. “A good case that shows everyone’s memory can be wrong,” she wrote.

But bigger questions about the scale of the online vitriol from parts of the Chinese and Chinese-American community remain. “I really haven’t known China for 20-something years, and it didn’t occur to me that what I wrote would generate so much anger,” she said. In the last years, “as China got stronger, nationalistic views got stronger,” she said, making a “civil conversation” about disagreements apparently harder.

Additional reporting by Cindy Hao in Seattle.

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